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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 510 Introduced in House (IH)]

113th CONGRESS
  2d Session
H. RES. 510

Expressing the sense of the House of Representatives that the National 
Institutes of Health should develop a pilot program to improve medical 
    trial participation, retention, efficiency, effectiveness, and 
                               diversity.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 11, 2014

Mr. Kingston submitted the following resolution; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                               RESOLUTION

 
Expressing the sense of the House of Representatives that the National 
Institutes of Health should develop a pilot program to improve medical 
    trial participation, retention, efficiency, effectiveness, and 
                               diversity.

Whereas clinical trials are essential for improving our Nation's health;
Whereas economically disadvantaged individuals, the elderly, females, and ethnic 
        and racial minority groups, especially African-Americans, Hispanic or 
        Latino Americans, Native Americans or Native Alaskans, Asian or Pacific 
        Islanders, are underrepresented in clinical trials, thereby threatening 
        the applicability of trial results for the general population;
Whereas minority groups account for more than 30 percent of the United States 
        population, yet collectively represented only 12.3 percent of all 
        publically funded cancer trials from 2003 to 2005;
Whereas a 2012 study supported by the National Cancer Institute found that in 
        patients 65 and older lower income predicted lower trial participation, 
        even while being nearly universally covered by the Medicare program;
Whereas a national survey of cancer patients found that 85 percent of 
        respondents were unaware that participating in a clinical trial was an 
        option for them;
Whereas cancer patients with annual incomes of less than $20,000 are 44 percent 
        less likely and those with annual incomes of less than $50,000 are 30 
        percent less likely to participate in clinical trials than cancer 
        patients with higher incomes;
Whereas in a 2001 survey of African-American physicians, 93 percent of 
        physicians cited lack of patient awareness as a possible factor 
        contributing to low rates of African-American trial participants and 92 
        percent of physicians cited mistrust of the medical community;
Whereas lack of health insurance is a major concern for potential trial 
        participants, with only 5.4 percent of all National Cancer Institute 
        sponsored cancer treatment trial participants being patients who choose 
        to participate despite not having health insurance;
Whereas a 2007 to 2011 study found that 53 percent of patients earning less than 
        $20,000 were concerned about how to pay for a trial, compared to 25 
        percent of patients that earned more than $100,000;
Whereas the National Institute of Health Revitalization Act of 1993 requires 
        applicants for Federal research funding to provide a strategy for 
        inclusion of women and people of diverse racial and ethnic origins into 
        clinical trials, but 21 percent of studies having received Federal 
        research funding since then have failed to report sample sizes by racial 
        or ethnic group; 64 percent did not provide any analysis by racial or 
        ethnic group; and 75 percent did not report any outcomes by sex; and
Whereas increasing participation rates of underrepresented demographic groups in 
        clinical trials would give physicians and researchers greater confidence 
        that the results of those trials would apply as broadly as possible to 
        all patients in the population: Now, therefore, be it
    Resolved, That it is the sense of the House of Representatives 
that--
            (1) the National Institutes of Health is encouraged to use 
        its existing budget and authority to establish a pilot 
        partnership with nonprofit organizations that hold prior 
        experience and expertise in diverse community outreach and 
        trial accrual in order to increase the efficiency and 
        effectiveness of clinical trials of the National Institutes of 
        Health, increase patient enrollment and retention in such 
        trials, and address the lack of diversity in such trials; and
            (2) the goals of the pilot partnership should include, but 
        should not be limited to, providing clinical trial navigation 
        services to help patients find, enroll, and manage the 
        logistical issues related to enrollment and retention in 
        federally supported clinical trials, and to improve 
        participation by populations such as underrepresented and 
        uninsured individuals in appropriate clinical trials.
                                 <all>
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